Manager, Controlled Substances

Role Summary

The Controlled Substance Compliance Manager oversees processes related to controlled substances, ensuring compliance with DEA and BNE regulations governing storage, handling, distribution, and reporting. The role supports leadership during regulatory audits, safeguards inventory integrity, and helps internal stakeholders meet business requirements for Controlled Substance Management. It also involves developing and executing SOPs, leading cross-department collaboration, and maintaining the organization’s controlled substances program throughout their lifecycle.

Responsibilities

• Ensures compliance with DEA regulations (21 CFR Part 1300) and BNE laws regarding handling, storage, distribution, and destruction of controlled substances.
• Serves as a DEA Subject Matter Expert and provides regulatory support as needed.
• Updates organizational policies in response to changes in controlled substance regulations.
• Assists during DEA audits and other inspections to ensure compliance and address concerns.
• Holds Power of Attorney for DEA Registrations.
• Maintains current facility Controlled Substance registrations, permits, and state licenses with timely submissions.
• Ensures DEA 222 Forms and required documents are completed accurately and on time.
• Manages discrepancy investigations and files DEA106 Reports as necessary.
• Coordinates destruction of controlled substances with internal stakeholders and the local DEA office; forwards completed DEA Form 41s.
• Maintains comprehensive records of controlled substance activities, including inventory logs, audit reports, and regulatory filings.
• Reviews shipping and receiving documents for accuracy and regulatory compliance.
• Prepares and submits all required reports to regulatory agencies in a timely manner.
• Performs critical calculations pertaining to controlled substance accountability.
• Prepares DEA correspondence and informational packages as required.
• Coordinates tracking, documentation, and reconciliation of inventories across all locations per SOPs and CFR requirements.
• Performs monthly safe inventories and semi-annual internal audits.
• Participates in evaluating inventory variances, deviations, and investigations related to controlled substances.

Qualifications

• Bachelor’s or advanced degree in a scientific field, healthcare, or criminal justice is preferred.
• 5+ years of experience in controlled substance management, regulatory compliance, or related field.
• Experience in pharmaceutical, biotechnology, or healthcare industry is highly preferred.
• Knowledge of DEA regulations (21 CFR Part 1300) and familiarity with BNE laws and regulations.
• Knowledge of DEA regulations, FDA guidelines, and other laws governing controlled substances.
• Familiarity with controlled substance inventory management systems and software.
• Strong analytical skills with ability to identify compliance risks and implement solutions.
• Certification in Regulatory Affairs (RAC) or related credential is a plus.